MedTrace Logo

Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease

NCT00478088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2025-12-19

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.

Conditions

  • Cervical Disc Degenerative Disorder

Interventions

DEVICE

NeoDisc

The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.

DEVICE

Instrumented Anterior Cervical Discectomy and Fusion (ACDF)

Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Scott Kitchel, MD · Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-08-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00478088 on ClinicalTrials.gov